Disclosed is a multiple electrode, closed-loop, responsive system for the treatment of certain neurological diseases such as epilepsy, migraine headaches and Parkinson's disease. Brain electrodes would be placed in close proximity to the brain or deep within brain tissue. When a neurological event such as the onset of an epileptic seizure occurs, EEG signals from the electrodes are processed by signal conditioning in a control module that can be placed beneath the patient's scalp, within the patient's chest, or situated externally on the patient. Neurological event detection means in the control module will then cause a response to be generated for stopping the neurological event. The response could be an electrical signal to brain electrodes or to electrodes located remotely in the patient's body. The response could also be the release of medication or the application of a sensory input such as sound, light or mechanical vibration or electrical stimulation of the skin. The response to the neurological event can originate from devices either internal or external to the patient. The system also has the capability for multi-channel recording of EEG related signals that occur both before and after the detection of a neurological event. Programmability of many different operating parameters of the system by means of external equipment provides adaptability for treating patients who manifest different symptoms and who respond differently to the response generated by the system.
Legal claims defining the scope of protection, as filed with the USPTO.
1. A method for recording data with a device implantable within a body of a patient having a brain, wherein the device comprises a processing subsystem, a memory subsystem, and a first sensor adapted to sense at least one signal from the brain, the method comprising the steps of: receiving a sensed signal representative of electrical activity in the brain from the first sensor; processing the sensed signal with the processing subsystem to create processed data; and storing the processed data in the memory subsystem.
2. The method of claim 1 , wherein the processing subsystem comprises an analog section and a digital section, and wherein the processing step comprises the steps of: operating the analog section to transform the sensed signal into a processed signal; and operating the digital section to transform the processed signal into processed data.
3. The method of claim 2 , wherein the processing subsystem further comprises an analog-to-digital converter, and the processing step further comprises performing an analog-to-digital conversion to create a sequence of samples.
4. The method of claim 3 , wherein the processing step further comprises the step of performing data compression on the sequence of samples.
5. The method of claim 4 , wherein the step of performing data compression comprises the step of encoding each sample in the sequence of samples.
6. The method of claim 4 , wherein the step of performing data compression comprises the step of performing a time-domain operation on the sequence of samples.
7. The method of claim 6 , wherein the step of performing a time-domain operation comprises filtering the sequence of samples.
8. The method of claim 2 , wherein the step of operating the digital section comprises the step of transforming the processed data into the frequency domain.
9. The method of claim 8 , wherein the step of operating the digital section further comprises the step of determining an energy level in at least one frequency band.
10. The method of claim 1 , wherein the processing subsystem and the memory subsystem are contained within a control module.
11. The method of claim 10 , wherein: the sensor comprises at least one electrode adapted to sense an electrical potential relative to a common electrode; and the control module has an outer housing defining the common electrode.
12. The method of claim 1 , further comprising the steps of: retrieving at least a portion of the processed data from the memory subsystem; and transmitting the portion of the processed data to external equipment.
13. The method of claim 12 , further comprising the step of receiving a command from the external equipment before the retrieving and transmitting steps.
14. The method of claim 12 , wherein the storing step and the transmitting step are performed substantially simultaneously.
15. The method of claim 12 , wherein the transmitting step is performed by a telemetry subsystem.
16. The method of claim 15 , wherein the telemetry subsystem is bi-directional.
17. The method of claim 15 , wherein the telemetry subsystem is adapted to transmit and receive information via electromagnetic waves.
18. The method of claim 15 , wherein the telemetry subsystem is adapted to transmit and receive information via acoustic waves.
19. The method of claim 1 , wherein the sensed signal represents an electroencephalogram (EEG) signal.
20. The method of claim 1 , wherein the first sensor comprises a brain electrical activity sensor.
21. The method of claim 20 , wherein the patient has a head, and wherein the method further comprises the step of implanting the brain electrical activity sensor in the head of the patient in a position selected to allow the brain electrical activity sensor to receive the sensed signal.
22. The method of claim 20 , wherein the brain electrical activity sensor is implanted within the brain of the patient.
23. The method of claim 22 , wherein the brain electrical activity sensor is located in close proximity to an epileptic focus.
24. The method of claim 20 , wherein the brain electrical activity sensor is located near a surface of the brain of the patient.
25. The method of claim 1 , wherein the sensor comprises at least one electrode.
26. The method of claim 1 , wherein the sensor comprises an electrode adapted to sense an electrical potential relative to a common electrode.
27. The method of claim 26 , wherein the common electrode is coupled to the device.
28. The method of claim 1 , wherein the sensor comprises an array having a plurality of electrodes, and wherein the sensor is adapted to sense an electrical potential between a first electrode and a second electrode.
29. The method of claim 1 , wherein the processing step comprises the step of amplifying the sensed signal by a gain factor.
30. The method of claim 29 , wherein the sensed signal has an average energy, and wherein the processing step further comprises the step of adjusting the gain factor to maintain the average energy of the sensed signal.
31. The method of claim 1 , wherein the patient has a head with a cranium, and wherein the method further comprises the step of implanting the device in the cranium.
32. The method of claim 1 , wherein the device further comprises a second sensor.
33. The method of claim 32 , wherein the second sensor comprises a brain electrical activity sensor adapted to sense at least one signal from the brain.
34. The method of claim 3 , wherein the second sensor comprises a brain electrode.
35. The method of claim 32 , wherein the second sensor is adapted to detect a physiological condition of the patient.
36. The method of claim 35 , wherein the second sensor is adapted to detect blood pressure.
37. The method of claim 32 , further comprising the steps of: receiving a second signal from the second sensor; processing the second signal with the processing subsystem to create secondary processed data; and storing the secondary processed data in the memory subsystem.
38. The method of claim 37 , the step of storing the processed data and the step of storing the secondary processed data are performed substantially simultaneously.
39. The method of claim 38 , wherein the secondary processed data stored in the second portion of the memory subsystem represents a different data type from the processed data stored in the first portion of the memory subsystem.
40. The method of claim 37 , wherein the memory subsystem has a plurality of portions, and wherein the step of storing the processed data comprises storing the processed data in a first portion of the memory subsystem, and wherein the step of storing the secondary processed data comprises storing the secondary processed data in a second portion of the memory subsystem.
41. The method of claim 1 , wherein the memory subsystem comprises a digital memory.
42. The method of claim 41 , wherein the digital memory comprises random access memory.
43. The method of claim 1 , wherein the memory subsystem comprises a first-in-first-out (FIFO) memory.
44. The method of claim 43 , wherein the memory subsystem further comprises random access memory.
45. The method of claim 44 , wherein the FIFO memory comprises at least a portion of the random access memory.
46. The method of claim 44 , further comprising the steps of: detecting a neurological event in the processed data; identifying pre-event data in the FIFO memory, wherein the pre-event data comprises a first time period of processed data from before the neurological event; identifying post-event data in the FIFO memory, wherein the post-event data comprises a second time period of processed data from after the neurological event; saving the pre-event data and the post-event data in the random access memory.
47. The method of claim 1 , wherein the memory subsystem has a plurality of portions, and wherein the step of storing the processed data comprises storing the processed data in a first portion of the memory subsystem, and wherein the method further comprises the step of storing a data item in a second portion of the memory subsystem.
48. The method of claim 47 , wherein the data item comprises a record representative of an actual time and date corresponding to a neurological event, an actual time and date corresponding to an action performed by the device, a detected neurological event, or an action performed by the device.
49. The method of claim 1 , wherein the processing step comprises identifying a neurological event in the sensed signal.
50. The method of claim 49 , wherein the processing subsystem includes an event detection section, and wherein the step of identifying a neurological event is performed by the event detection section.
51. The method of claim 50 , wherein the step of identifying a neurological event comprises the steps of: incrementing a counter upon identification of a specified condition in the sensed signal; and storing a data item corresponding to the specified condition in the memory subsystem.
52. The method of claim 51 , wherein the step of identifying a neurological event comprises determining whether the counter exceeds a threshold, and if so, generating an event signal representative of an occurrence of the neurological event.
53. The method of claim 52 , further comprising the steps of: storing a data item representative of the event signal in the memory subsystem; and performing an action in response to the occurrence of the neurological event.
54. The method of claim 52 , wherein the neurological event comprises an epileptic seizure, a precursor to an epileptic seizure, a Parkinson's tremor, a precursor to a Parkinson's tremor, a migraine headache, or a precursor to a migraine headache.
55. The method of claim 51 , further comprising the step of resetting the counter at an end of a detection window.
56. The method of claim 49 , wherein the neurological event comprises data representative of a seizure, and wherein the method further comprises the step of stimulating the patient in response to the neurological event.
57. The method of claim 56 , wherein the step of stimulating the patient comprises applying an electrical signal to a portion of the patient's brain.
58. The method of claim 56 , wherein the step of stimulating the patient comprises applying a sensory stimulus to the patient.
59. The method of claim 56 , wherein the storing step and the stimulating step are performed substantially simultaneously.
60. The method of claim 49 , wherein the neurological event comprises data representative of a precursor to a seizure, and wherein the method further comprises the step of stimulating the patient in response to the neurological event.
61. The method of claim 49 , further comprising the steps of: identifying pre-event data in the processed data, wherein the pre-event data comprises a first time period of processed data from before the neurological event; identifying post-event data in the processed data, wherein the post-event data comprises a second time period of processed data from after the neurological event; retrieving the pre-event data and the post-event data from the memory subsystem; and transmitting the pre-event data and the post-event data to external equipment.
62. The method of claim 61 , wherein the first time period is between approximately 0.1 minutes and approximately 30 minutes, and wherein the second time period is between approximately 0.1 minutes and approximately 30 minutes.
63. The method of claim 1 , further comprising the step of receiving a command from external equipment.
64. The method of claim 63 , wherein the command received from the external equipment comprises a request for the device to perform an action.
65. The method of claim 63 , wherein the command received from the external equipment comprises a request for the device to switch into a different mode.
66. The method of claim 63 , wherein the command received from the external equipment comprises a request for the device to perform the storing step.
67. The method of claim 63 , wherein the external equipment comprises a physician's workstation.
68. The method of claim 63 , wherein the external equipment comprises an patient's initiating device.
69. A method for recording data with a device implantable within a body of a patient having a brain, wherein the device is adapted for communication with external equipment, the method comprising the steps of: receiving a sensed signal representative of electrical activity in the brain from the first sensor; processing the sensed signal with the processing subsystem to create processed data; storing the processed data in the memory subsystem; receiving a command from an external apparatus; processing the command to identify an action associated with the command; and performing the action associated with the command.
70. The method of claim 69 , wherein the action associated with the command comprises transmitting at least part of the processed data to the external equipment.
71. The method of claim 70 , wherein the performing step comprises the steps of: identifying a portion of the processed data in the memory subsystem; retrieving the portion of the processed data from the memory subsystem; and transmitting the portion of the processed data to the external equipment.
72. A method for recording data representative of a neurological event with a device implantable within a body of a patient having a brain, wherein the device has a processing subsystem, a memory subsystem, and at least one sensor adapted to sense at least one signal from the brain, the method comprising the steps of: receiving a sensed signal representative of electrical activity in the brain from the first sensor; processing the sensed signal with the processing subsystem to create processed data; identifying a neurological event in the processed data; identifying pre-event data in the processed data; identifying post-event data in the processed data; generating a data item associated with the neurological event; and storing the pre-event data, the post-event data, and the data item in the memory subsystem.
73. The method of claim 72 , further comprising the steps of: receiving a command from external equipment; determining whether the command is a request to transmit data; and if so, transmitting the pre-event data, the post-event data, and the data item to the external equipment.
74. The method of claim 73 , wherein the storing step and the transmitting step are performed substantially simultaneously.
75. A method for recording data with a device implantable within a body of a patient having a brain, wherein the device comprises a processing subsystem, a memory subsystem, a plurality of sensors adapted to sense electrical activity in a plurality of locations in the brain, and a stimulation subsystem adapted to treat the patient in response to a neurological event detected by the device, the method comprising the steps of: receiving a plurality of signals representative of electrical activity in the brain from the plurality of sensors; processing the plurality of signals with the processing subsystem to create a plurality of streams of processed data; and storing at least one stream of processed data in the memory subsystem.
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August 2, 2000
March 19, 2002
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